MAUDE Adverse Event Report: SYNTHES GMBH 2.8MM THREADED DRILL GUIDE; GUIDE, SURGICAL, INSTRUMENT

Catalog Number	312.648
Medical Device Problem Code	Device-Device Incompatibility (2919)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported during a procedure on (b)(6) 2024, the devices became stuck together when inserting the drill guide.Devices would not come apart.Staff used the other driver and drill guides to complete the case.No delay in case and no patient status/ outcome / consequences.Procedure completed successfully.This report is for one 2.8mm threaded drill guide for (b)(4).
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.If the information is unknown, not available or does not apply, the section/field of the form is left blank.H11 additional narrative: e1: initial reporter is j&j company representative h3, h6: the device was received, the investigation is in progress, no conclusion could be drawn at the time of filing this report.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on information which depuy synthes has not been able to investigate or verify prior to the required reporting date.This report does not reflect a conclusion by fda, depuy synthes or its employees that the report constitutes an admission that the device, depuy synthes, or its employees caused or contributed to the potential event described in this report.H3, h6: the product was returned to depuy synthes for evaluation.Visual inspection of the returned device found that the 2.8mm threaded drill guide (312.648) was assembly whit the sddrive(tm) screwdriver t15 (314.115).No other issue was found.Functional test was preformed.Several disassembly attempts were made.Disassembly was impossible.A dimensional inspection was not performed since it was not applicable to the complaint condition.The following recommendations, annotations and alternatives are mentioned in the proximal tibial proximal plate surgical technique guide insert 3.5 mm locking screws in shaft of plate: - attach the 2.8 mm threaded drill guide (312.648) to a locking hole in the plate shaft.Drill a hole using the 2.8 mm percutaneous drill bit (324.214).Note: -use of the drill guide is mandatory for screws to lock to the plate properly.-determine the appropriate screw length indicated on the calibrated drill bit.-remove the drill bit and drill guide.-insert the appropriate length locking screw into the bone with power, using the 1.5 nm torque limiting attachment (tla) (511.770 or 511.773) and stardrive or hexagonal screwdriver shaft (314.116 or 314.030).Note: -always use the tla (torque limiting attachment) when using power.-repeat as necessary to insert additional locking screws.-examine the limb clinically and radiographically.It is important that the tibial plateau is in proper orientation to the tibial shaft.Alternative use the stardrive or hexagonal screwdriver (314.115 or 314.070) to manually insert the appropriate locking screw.Carefully tighten the locking screw, as excessive force is not necessary to produce screw-to-plate locking.The overall complaint was confirmed as the observed condition of the 2.8mm threaded drill guide would have contributed to the complained device issue.Based on the investigation findings, the potential cause is traced to user, and it has been determined that no corrective and/or preventative action is proposed.There is no indication that a design or manufacturing issue has caused the reported complaint condition.As part of depuy synthes quality process, all devices are manufactured, inspected, and released to approved specifications.Additional monitoring for any potential safety signals will be conducted through complaint trending and other post-market safety surveillance activities.Device history review (dhr): part: 312.648, lot no:3l58603, release to warehouse date: 01 apr, 2019, manufacturing site: werk hagendorf.A manufacturing record evaluation was performed for the finished article lot and no non-conformances were identified.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 2.8MM THREADED DRILL GUIDE
• Common Device Name: GUIDE, SURGICAL, INSTRUMENT
• Manufacturer (Section D): SYNTHES GMBH; luzernstrasse 19-21; zuchwil 4528 ; SZ 4528
• Manufacturer (Section G): WERK HAEGENDORF; im bifang 6; haegendorf CO ; SZ
• Manufacturer Contact: kate karberg ; 1302 wright lane east; west chester, PA 19380 ; 3035526892
• MDR Report Key: 20168325
• Report Number: 8030965-2024-10927
• Device Sequence Number: 8031824
• Product Code: FZX
• UDI-Device Identifier: 10886982187840
• UDI-Public: (01)10886982187840(11)190410(17)390404(10)3L58603
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 312.648
• Device Lot Number: 3L58603
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/13/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2019
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown